Barzolvolimab (CDX-0159) - (EMBARQ-CSU2)

June 14, 2026: Celldex (NASDAQ: CLDX) presented long-term Phase 2 results for barzolvolimab in antihistamine-refractory chronic spontaneous urticaria (CSU) during a flash talk at the EAACI Annual Meeting in Istanbul. The update focused on CSU-associated angioedema, reporting rapid, significant, and durable improvements, with symptom relief beginning as early as Week 1 and deepening through 52 weeks of treatment. Newly presented follow-up data showed sustained off-treatment benefit at Week 76 (seven months after the last dose), with up to 64% of patients who had angioedema at baseline remaining angioedema-free.

The underlying Phase 2 CSU study was randomized, double-blind, placebo-controlled (208 patients) and met its primary endpoint: statistically significant mean change from baseline to Week 12 in UAS7 versus placebo across all tested dose levels (75 mg Q4W, 150 mg Q4W, 300 mg Q8W).

Celldex said two Phase 3 CSU trials are ongoing with enrollment complete (1,939 patients across 43 countries/500 sites). Topline Phase 3 data are expected in Q4 2026, supporting a planned BLA submission in 2027.